An Evaluation of Method Reporting and Use in Clinical Trials in Dermatology

How Well Are Randomized Controlled Trials Reported in the Dermatology Literature?

“…These problems suggest that many of these studies may have exaggerated treatment effects. 14 Our results agree with other surveys 19,20,22,23,25,26 that described inadequate execution and/or reporting of RCTs.…”

“…Formulating a clear trial hypothesis necessarily leads to the determination of the sample size needed to minimize both type I (falsely claiming a treatment effect when there is none) and type II errors. TheproblemsofqualityofRCTshighlightedabovehave been equally documented for other specialties and journals 19,20,22,23,25,26 and underscore the importance of standards of reporting across medical disciplines. Again, the quality of reporting of RCTs is taken as a proxy for the quality of the trials themselves.…”

“…As part of the group's work of assembling and assessing all the evidence for the effectiveness of skin treatments, we identified, by hand searching, 18 all the clinical trial reports in Clinical and Experimental Dermatology, a major source of reports of skin trials. Earlier research suggested that the methodological quality of skin trials may be limited, 19,20 and we wanted to see the overall quality of the reporting of these trials. We assessed the methodological and reporting qualities of each of the trial reports according to the dimensions of the main features of RCTs.…”

A Randomized Controlled Trial of Belimumab for the Treatment of Active Systemic Lupus Erythematosus

“…1 This was a high-quality study that showed a modest statistically significant benefit for the addition of belimumab to standard care in the treatment of systemic lupus erythematosus (SLE). 2,3 Randomization was performed using a central telephone-based system on a 1:1:1 basis and was stratified according to SELENA-SLEDAI score (Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index), 4 proteinuria concentration at screening, and ethnic origin. Masking was maintained until the database was finalized.…”

Analysing the Structure of 23 Clinical Trials in Multiple Sclerosis

“…In order to consider the relationship between the theory of such trials and their practice, the definition of a trial used in the selec tion of the reports has been that of the author(s). Using this definition re sulted in the imposition of criteria similar to that employed by Bigby et al [34],…”